Genitourinary Tumors With Sacituzumab Tirumotecan
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD
About this trial
RINGQUEST is a Phase 2, open-label, single arm, basket, investigator-initiated clinical trial of sacituzumab tirumotecan in patients with:
* Cohort 1: papillary renal carcinoma (pRCC). * Cohort 2: less frequent bladder tumors such as variant histology urothelial carcinoma (VH-UC). The most common VH-UC are nested, microcystic, micropapillary, lymphoepithelioma-like, plasmacytoid, giant cell, poorly differentiated, lipid-rich, clear cell, sarcomatoid) bladder cancer and non-urothelial bladder cancer of epithelial origin including squamous cell carcinoma and adenocarcinoma (urachal and non-urachal).
Eligibility criteria
Qualifiers
The participant provides written informed consent for the study.
Be willing and able to comply with study procedures, laboratory tests, and other requirements of the study.
Cohort 1: papillary renal carcinoma (pRCC).
Cohort 1: Prior treatment with PD-1/PD-L1 and or tyrosine kinase inhibitors (TKIs)
Disqualifiers
Symptomatic brain metastases or leptomeningeal disease. Note: Participants with previously-treated brain metastases may participate provided they are radiologically stable (ie, without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during study screening, are clinically stable, and have not required steroid treatment for at least 14 days before the first dose of study intervention.
Has an active infection requiring systemic therapy other than those permitted in the inclusion criteria.
Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/interstitial lung disease or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at screening
Trial design
Treatments tested in this trial
- Sacituzumab Tirumotecan (SKB264)
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
MFAR
Collaborator
Source ClinicalTrials.gov